The FDA released draft guidance today informing manufacturers, distributors and other med-tech entities about the agency’s intentions to regulate mobile health apps as medical devices.
Medical applications on smartphones, tablets and other mobile devices range from programs that allow patients to watch their calorie intake or keep records of blood pressure readings to apps that allow physicians to view and share medical images on the go.
The agency’s draft guidance, which it first promised to deliver in March, considers regulation for a subset of mobile apps that "may impact the performance or functionality of currently regulated medical devices."
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in a prepared release. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."
Several mobile medical programs have already passed FDA review for the U.S. market, including two consumer-friendly blood pressure cuffs that track and store blood pressure readings on smartphones (which won clearance in June), GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’s MobiUs and MIM Software’s Mobile MIM.
The apps in question fit into one of two categories: (1) those used as an accessory to an FDA-regulated device, or (2) those that turn mobile devices into medical devices using attachments, sensors or other hardware or software technology.
The intended use of the app will determine whether it fits into one of those categories, according to the draft guidance.
The agency also outlined several categories of apps that won’t require oversight, including ones used solely to log or record information, ones that automate administrative duties like billing or inventory and programs that provide "copies" of medical texts.